Federal Circuit Provides More Guidance On Biosimilar Patent Litigation

In Amgen Inc. v. Hospira, Inc.the Federal Circuit held that Amgen could not obtain discovery related to activities that might infringe a patent that it had not asserted in its biosimilar patent litigation against Hospira. In particular, the court held that it lacked jurisdiction—under the collateral order doctrine—over the district court’s denial of Amgen’s motion to compel discovery regarding the cell-culture medium Hospira uses to make its biosimilar product. The court also held that Amgen had failed to show its “clear and indisputable’” right to the information as required for a writ of mandamus.


Any opinions expressed in this article are personal to the authors and do not reflect the views of Foley & Lardner LLP, its partners, or its clients.


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Federal Circuit Criticizes PTAB Reliance On Routine Testing

In Honeywell International, Inc. v. Mexichem Amanco Holdings S.A. DE C.V., the Federal Circuit vacated the decision of the USPTO Patent Trial and Appeal Board that invalidated Honeywell’s patent in an inter partes reexamination proceeding. The court’s decision could be important to applicants and patent owners facing obviousness rejections based on inherency and routine testing.


Any opinions expressed in this article are personal to the author and do not reflect the views of Foley & Lardner LLP, its partners, or its clients.


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A Look At The USPTO Patent Eligible Subject Matter Report

On July 24, 2017, the USPTO issued a 48-page report on Patent Eligible Subject Matter. The report summarizes key court decisions interpreting and applying 35 USC § 101, international views on eligible subject matter, and public comments and recommendations for addressing recent changes in this foundational issue of U.S. patent jurisprudence. While some have criticized the USPTO Patent Eligible Subject Matter report for failing to take a position on the issues or suggest any solutions, others have commended the concise summary of where things stand today. Continue reading this entry

Federal Circuit Finds Regeneron Transgenic Mouse Patent Invalid For Inequitable Conduct With Intent Inferred From Litigation Misconduct

In a 38 page decision with a 19 page dissent by Judge Newman, the Federal Circuit determined that Regeneron’s transgenic mouse patent is unenforceable due to inequitable conduct. The decision was rendered in Regeneron Pharmaceuticals v. Merus N.V., where the requisite intent to deceive was inferred as a sanction for Regeneron’s “widespread litigation misconduct.” Chief Judge Prost and Judge Wallach agreed such a sanction was permissible, while Judge Newman urged otherwise.

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Federal Circuit Finds Velcade Patent Not Obvious Under Lead Compound Analysis

In Millennium Pharmaceuticals, Inc. v. Sandoz, the Federal Circuit reversed the district court decision that invalidated one of the Orange Book-listed patents covering the anti-cancer drug Velcade. In so doing, the court explained that a novel product with unexpected advantageous properties is not obvious just because the process by which it was made might have been.

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